“OLANI PK/Safety Study in Healthy Volunteers”
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
Drug - naltrexone implant
1.8 g implant containing 60% naltrexone
A Pilot Pharmacokinetic (PK) Trial of the O'Neil Long Acting Naltrexone Implant